study of adalimumab treatment for induction and maintenance of clinical remission in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe crohn's disease (cd) and to measure the effects of treatment on patient general well-being, health-related quality of life (qol), fistula healing, cd-related extra-intestinal manifestations, work performance, and overall activity.

this is an open-label, multi-center, study designed to evaluate the safety and efficacy of adalimumab on inducing and maintaining clinical remission in subjects with moderate to severe crohn's disease. approximately 1000 subjects with a diagnosis of moderate to severe crohn's disease (harvey bradshaw index score \>= 7) will be enrolled at approximately 200 sites within europe. enrollment will be dependent on meeting all screening criteria. study medication will be administered by subcutaneous injection. at baseline (week 0), all subjects will receive a dose of 160 mg adalimumab. at week 2, all subjects will receive a dose of 80 mg adalimumab. starting at week 4, all subjects will begin receiving injections of adalimumab 40 mg every other week and will continue every other week dosing through week 20 except in the case of disease flare or non-response. starting at week 12, subjects who experience a disease flare (flare is defined by an increase in the harvey bradshaw index \>=3 and a total index score of \>=7 when compared to week 4) or are not responding to adalimumab treatment (non-response is defined as a decrease in the harvey bradshaw index by fewer than 3 points compared to baseline) will be permitted to increase study therapy to adalimumab 40 mg every week. if the subject continues to demonstrate a lack of improvement on every week adalimumab therapy, they may be withdrawn from the study. prior to week 8 subjects will not be allowed to increase or decrease crohn's specific concomitant medications except in the event of concomitant crohn's treatment-related toxicities assessed as moderate to severe. changes in concomitant medications at/after week 8 will be at the investigator's discretion. subjects will be evaluated for safety and efficacy at baseline (week 0), weeks 2, 4, 8, 12, and 20, and at unscheduled visits. efficacy evaluations include hbi, short inflammatory bowel disease questionnaire (sibdq), work productivity activity index (wpai) questionnaire, fistula counts, health care resource utilization (hcru), and evaluation of cd-related extra-intestinal manifestations (eims). safety assessments include vital signs, physical examination, general laboratory analyses, urinalysis, and monitoring of adverse events (aes).

Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe crohn's disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks) * inadequate response to conventional therapy for crohn's disease * subjects \>=18 and \<=75 years of age and in good health (investigator discretion) with a recent stable medical history * harvey bradshaw index score of 7 or higher exclusion criteria: * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study * female subject who is pregnant or breast-feeding or considering becoming pregnant * previous treatment with adalimumab or previous participation in an adalimumab clinical study * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * subjects with any prior exposure to tysabri® (natalizumab) * subjects on prednisone \>40 mg/day (or equivalent), subjects on budesonide \>9 mg/day, or subjects who are taking prednisone and budesonide concurrently at baseline